Two-part non-planar graduated compression device for the treatment of circulatory disorders

ABSTRACT

A therapeutic compression garment made from body and band portions wherein at least one of the body and spine portions is narrower or wider across its mid-section than at either or both of its top and bottom edges such that the garment assumes a non-planar shape when the body and spine portions are attached together.

RELATED APPLICATION

The present invention is a continuation-in-part of U.S. application Ser.No. 12/952,065, entitled “Graduated Compression For The Treatment OfCirculatory Disorders”, filed Nov. 22, 2012, which in turn claimspriority to U.S. Provisional Patent Application No. 61/264,213, entitled“Graduated Compression For The Treatment Of Circulatory Disorders”,filed Nov. 24, 2009, the entire disclosures of which are incorporated byreference herein in their entirety.

TECHNICAL FIELD

The present invention relates to devices that treat circulatorydisorders such as lymphedema, edema and venous diseases.

BACKGROUND OF THE INVENTION

A common treatment for circulatory disorders such as lymphedema, edemaand venous diseases is to wear a compression garment. Currentcompression garments are available in various ready-to-wear standardsizes. Unfortunately, a wide array of inventory must be kept on handwhen distributing ready-to-wear garments in order to accommodate thepopulation majority. Although compression garments have been designedthat can be modified in circumference or length to obtain a better fit,the “nearest” size must still be chosen.

Alternatively, custom made-to-measure garments have also been producedas a form of treatment. Unfortunately, measuring, sizing, and orderingthese made-to-measure garments is time consuming and may still notresult in a properly fitted compression garment. For limbs that areoutside of the standard ready-to-wear size range, custom garments needto be built to match the curvature, length and circumference of thelimb. As a result, many measurements are needed to make these customgarments and there is a period between measuring, ordering, productionand fitting of the garment where the limb profile may change, which canresult in an improper fit due to the time it takes for the patient toreceive their garment.

Various compression garments have tried trimming-to-fit methods wherelonger bands are cut down from the largest size to fit the patient.Unfortunately, these bands need to be trimmed separately or in pairs andangled in a manner that best conforms to the shape of the limb. This isa slow and time consuming process. Working out the correct lengths andangles of each band can be very difficult, and is often made moredifficult due to the fact that the bands need to overlap to obtaincomplete coverage.

Other compression modalities such as bandaging have also been used. Anadvantage of bandaging is that it can be used on 100% of the populationwith one inventory set. Unfortunately, bandaging is very time consumingand does not have the benefit of quick and easy application as comparedto standard compression garments. In addition, bandaging is notguaranteed to provide reliable/consistent compression levels., andcannot be adjusted as the limb shape and compression needs change.

SUMMARY OF THE INVENTION

The present invention provides a one-size-fits-all compression garmentthat can easily and quickly be tailored to match the circumferenceprofile of a particular patient's limb.

In a preferred embodiment, the present invention provides a therapeuticcompression garment, comprising: a body portion having a plurality ofbands extending from one side; and a spine portion having a plurality ofbands extending from one side, wherein the bands extending from the bodyportion and the bands extending from the spine portion attach the bodyand spine portions together when the body and spine portions are wrappedaround a body limb, and wherein the spine portion is releasably attachedonto the body portion such that the spine portion is positionable atdifferent locations on the body portion. The present invention providestherapeutic compression. The spine portion is attached to the bodyportion at a preferred location, such that the garment best fits theparticular patient's limb.

The therapeutic compression garment may be fit onto a patient's limb byfirst measuring the circumference of the patient's limb at a toplocation, at a bottom location, and then the length of the limb. Next,the garment is assembled around the limb by: (i) aligning the spineportion and the body portion using measurement indicia (on one or theother of the body or spine portions); (ii) attaching the spine portiononto the body portion; (iii) optionally discarding an unused portion ofthe body portion; and then (iv) wrapping the assembled therapeuticcompression garment around the patient's limb, thereby securing thebands in their proper location.

It is to be understood throughout the specification that the presentinvention may be used on either a patient's arm or leg, and thatexamples referring to a leg are merely exemplary, and not limiting.

Preferably, hook and loop fasteners are used such that the body andspine portions are first attached together by hook and loop fasteners.After this has been done, the two piece device will then become acontinuous one piece garment. Next, the resulting one piece garment willthen be positioned behind the limb and the open front side will then bewrapped and fastened together around the front of the patient's limb.Preferably, the hook and loop fasteners holding the body and spineportions together are stronger than the hook and loop fasteners holdingthe bands to the body and spine portions when the garment is applied.Thus, pulling on the bands to tighten, adjust, or remove the garmentwill not cause the body and spine portions to pull apart. Therefore, theuser will be less likely to unintentionally disengage to the spineattachments while detaching the other bands.

In preferred embodiments, the top and bottom edges of the body portionare marked with measurement indicia and a curved edge of the spineportion is aligned with these measurement indicia, as follows. First,the top of the spine portion is aligned with the measurement indicia onthe body portion corresponding to the circumference measurement taken atthe top location on the patient's limb, and the bottom of the spineportion is aligned with the measurement indicia on the body portioncorresponding to the circumference measurement taken at the bottomlocation on the patient's limb. The spine portion is then attached ontothe body portion by one or more hook and loop fastener tabs (positionedalong a curved edge of the spine portion). In other embodiments, themeasurement indicia are displayed along the mid portions of either thespine or body portions. In the various embodiments of the presentinvention, these measurement indicia correspond to the circumference ofa particular patient's body limb, or to general body limb sizes such assmall, medium, large and extra large.

In various embodiments, after the body and spine portions have beenfastened together (but prior to wrapping the garment around thepatient's limb), if necessary the user simply discards the unusedportion by cutting off the excess.

An advantage of the present garment is that it can be provided in onesize for all patients (since the actual sizing and adjustment of thegarment can be done by the therapist or end user or clinician). Anotheradvantage of the present garment is that it is simple to put on and veryeasy for a clinician or end user to shape, size correctly, and adjustaccordingly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an illustration of the garment prior to attaching the bodyand spine portions together.

FIG. 1B is an illustration of the garment after attaching the body andspine portions together.

FIG. 2A is a close up of the top of the garment showing the alignment ofthe body and spine portions.

FIG. 2B is a close up of the bottom of the garment showing the alignmentof the body and spine portions.

FIG. 3A is an illustration of a first alignment of the body and spineportions (as suited for a patient having a small ankle and calf).

FIG. 3B is an illustration of a second alignment of the body and spineportions (as suited for a patient having a small ankle and medium calf).

FIG. 3C is an illustration of a third alignment of the body and spineportions (as suited for a patient having a small ankle and large calf).

FIG. 4 is an illustration of discarding an unused portion of the bodyportion after the body and spine portions have been attached together.

FIGS. 5A and 5B are sequential illustrations of the patient wrapping thegarment around their leg.

FIGS. 6A and 6B are a second embodiment of the present invention.

FIGS. 7A and 7B are third embodiments of the present invention.

FIG. 8 is a fourth embodiment of the present invention.

FIG. 9 is a fifth embodiment of the present invention.

FIG. 10 is a sixth embodiment of the present invention.

FIG. 11A is a seventh embodiment of the present invention.

FIG. 11B is a profile view of a band tab hook attachment of the garmentof FIG. 11A.

FIG. 11C is a profile view of a portion of the garment of FIG. 11A.

FIG. 11D is a profile view of spine tab hook attachment including stayof the garment of FIG. 11A.

FIG. 12A is a reverse side view of the garment shown in FIG. 11A.

FIG. 12B is a profile view of a portion of the garment of FIG. 12A.

FIG. 13A is an eighth embodiment of the present invention in an openposition (with the bands removed for clarity of illustration).

FIG. 13B is the garment of FIG. 13A in a closed position (with the bandsremoved for clarity of illustration).

FIG. 13C is an illustration corresponding to FIG. 13A (with the bandsshown).

FIG. 13D is a top plan view corresponding to FIG. 13B.

FIG. 14A is a plan view of an alternate embodiment with a guide band onthe body portion, wherein the guide band and the body portion wraptogether around the body limb.

FIG. 14B is similar to FIG. 14A, but instead has a pair of parallelguide bands.

FIG. 14C is another alternate embodiment with a guide band spanningbetween the body and spine portions of the garment.

FIG. 15A is a plan view of an alternate embodiment of the invention inwhich the garment assumes a non-planar shape when the ends of the bodyand spine portions are secured together.

FIG. 15B is an illustration of the body and spine portions held togetherby a notched connector, showing the non-planar shape of the garment.

FIG. 15C is another illustration of the body and spine portions heldtogether by a notched connector, showing the non-planar shape of thegarment from a different angle.

FIG. 15D is an illustration similar to FIG. 15B, but instead showing theinside surface of the garment.

FIG. 15E is an illustration of the side view of the garment of FIGS. 15Ato 15D, showing its non-planar shape.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring first to FIGS. 1A to 5B, a therapeutic compression garment 10is provided. Garment 10 comes in two pieces, being a body portion 20 anda spine portion 30. Body portion 20 has a plurality of bands 22extending from one side as shown. Spine portion 30 similarly has aplurality of bands 32 extending from one of its sides as shown.

As will be explained, the bands 22 extending from body portion 20 arejuxtaposed between the bands 32 extending from spine portion 30 whengarment 10 is wrapped around the patient's limb. Specifically, as seenin FIGS. 5A and 5B, bands 22 are fastened onto spine portion 30 andbands 32 are fastened onto body portion 20. Most preferably, bands 22and 32 have Velcro® (i.e.: hook and loop fastener) ends. Similarly, thesurfaces of body portion 20 and spine portion 30 are also covered withcorresponding Velcro® (i.e.: hook and loop fastener) surfaces. In someembodiments, bands 22 and 32 may extend past the spine divider (i.e.:the connection point between the body and spine portions) and back ontotheir own portions respectively.

In operation, the therapeutic compression garment 10 is fitted onto apatient's limb, as follows. First, the patient (or other personassisting the patient) measures the circumference of the limb at a toplocation and at a bottom location and the length of the limb. Forexample, the limb would be the leg, the top location would be the calf,the bottom location would be the ankle, and the leg length from ankle toknee crease would determine the preferred garment length.

Next, the patient assembles therapeutic compression garment 10 aroundtheir limb by: (i) aligning spine portion 30 with the measurementindicia on body portion 20 (as seen in close up FIGS. 2A and 2B); (ii)attaching spine portion 30 onto body portion 20; (iii) discarding anyunused portion of body portion 20; and then (iv) wrapping the assembledtherapeutic compression garment 10 around their leg (while juxtaposingbands 22 and 32 thereby securing bands 22 onto spine portion 30 andbands 32 onto body portion 20). As a result, the two piece garment shownin FIG. 1A is first changed into the one-piece garment shown in FIG. 1B.Next, as shown in FIG. 4, an unused portion 20A of body portion 20 isdiscarded. Finally, as shown in FIGS. 5A and 5B, garment 10 is wrappedaround the patient's leg.

As can be seen in FIGS. 3A to 3C, spine portion 30 is releasablyattached onto body portion 20. As a result, spine portion 30 ispositionable at different locations on body portion 20. This permitsspine portion 30 to be positioned at different locations depending uponthe dimensions of the patient's limb. Preferably, body and spineportions 20 and 30 are simply attached together by hook and loopfasteners. As illustrated, spine 30 may have three fastener tabs 34disposed along the curved edge of spine 30 (opposite to the side fromwhich bands 32 extend). The spacing selected between fastener tabs 34allows the spine curve (i.e.: the connection along which the body andspine portions 20 and 30 are attached together by fastener tabs 34) tobe positioned such that garment 10 starts to take a three dimensionalshape (as opposed to simply lying flat). This shaping helps the garmentto best fit the contours of the limb.

As can be seen, body portion 20 preferably has parallel top edge 21 andbottom edge 23. These top and bottom edges 21 and 23 of the body portionare marked with measurement indicia. As seen in the close up view ofFIGS. 2A and 2B, the curved edge of spine portion 30 is aligned with themeasurement indicia on the top and bottom edges 21 and 23 of bodyportion 20. Aligning spine portion 30 with the measurement indicia onbody portion 20 comprises aligning the top 31 of spine portion 30 withthe measurement indicia on the top 21 of body portion 20 correspondingto the circumference measurement taken at the top location on thepatient's limb (e.g.: at the calf). Similarly, aligning spine portion 30also comprises aligning the bottom 33 of spine portion 30 with themeasurement indicia on the bottom 23 of body portion 20 corresponding tothe circumference measurement taken at the bottom location on thepatient's limb (e.g.: at the ankle).

Fitting is done by measuring the patient's ankle and calfcircumferences. These circumference measurements are represented by arange of indicia markings along the top edge 21 and bottom edge 23 ofbody portion 20. The bottom markings reflect the ankle circumference andthe top markings reflect the calf circumference. The hook tabs 34 fromspine portion 30 are secured to body portion 20 according to where thepatient's ankle and calf circumference measurements fall within themarked ranges. Each tab 34 can be angled independently due to spacingbetween the tabs and any elasticity in the material used. This allowsspine tabs 34 to be further adjusted to create smooth transitions fromtop to bottom along spine portion 30. The spine's already curved edgeaids in mimicking the limb's natural contour. This feature, along withadjustable spine tabs 34, allows the garment to adjust to almost anylimb size and shape.

As seen in FIGS. 3A to 3C, a variety of different alignment positionsare possible (since each position will depend upon the exact ankle andcalf measurements of the particular patient). Specifically, FIG. 3Aillustrates a patient having a small ankle and calf FIG. 3B illustratesa patient having a small ankle and medium calf. FIG. 3C illustrates apatient having a small ankle and large calf, though any variation of legproportions can be addressed. After spine portion 30 has been properlyaligned, it is then simply pressed against body portion 20 such that itis held in position by hook and loop fasteners 34. (Note: the side ofbody portion 20 and spine portion 30 is preferably covered with a hookand loop fastener surface.)

Next, as shown in FIG. 4, spine portion 30 is simply pulled back aside,and the patient/clinician then cuts off the unused portion (designated20A) of body portion 20. Thus, the unused portion 20A is removed from aside opposite to the side from which bands 22 extend.

Next, as seen in FIGS. 5A and 5B, the assembled garment 10 is thenwrapped around the front of the leg, thereby securing bands 22 ontospine portion 30, and securing bands 32 onto body portion 20. Thus,bands 22 are simply fastened onto spine portion 30 by hook and loopfasteners. Similarly, bands 32 are attached to body portion 20 by hookand loop fasteners. Preferably, the hook and loop fasteners holding thebody and spine portions 20 and 30 together are stronger than the hookand loop fasteners holding the bands 22 and 32 to either of the body andspine portions 20 or 30. As a result, tightening, adjusting, ordisengaging bands 22 and 32 at the front of the garment does not pullapart the body and spine portions 20 and 30 at the back of the garment.The preferred difference in hook and loop strength provides the userwith additional guidance as to which hook tabs should be disengagedwhile doffing or adjusting the therapeutic garment. Optionally, one ormore reinforcement tabs 40 (see FIG. 11A) can also be used to furthersecure the body and spine portions 20 and 30 together. Reinforcementtabs 40 can similarly be made of hook and loop fastener surfaces suchthat they can attach directly on top of body and spine portions 20 and30 (to reduce the risk of the spine-to-body connection being disengagedalong the back of the garment).

The hook and loop fasteners may be secured directly on to the surface of(i.e.: sewn onto) the ends of bands 22 and 32. In contrast, the hook andloop fasteners may optionally extend from the edges of the body andspine portions 20 and 30. As a result, the addition of the hook and loopfasteners onto the body and spine portions 20 and 30 would not add anysignificant thickness to the final garment, reducing the risk ofaccidental spine tab 34 removal.

As illustrated, there are three tabs 34. It is to be understood that theinvention encompasses any number of tabs 34. For example, usingadditional smaller tabs (e.g.: four or more) can better match the limbprofile, however more adjustments would be necessary. The adhesionstrength of the spine to body portion connection may also be reduced dueto the increased number of spine tabs 34. Conversely, using fewer tabs34 (one or two) decreases the ability for the spine to contour to thelimb because current hook material available is inelastic in nature anddoesn't bend easily. If an elastic pliable hook were to be used, theentire curved portion of spine portion 30 could be made from one tab.

Alternatively, garment 10 may be provided to the user with portions 20and 30 already fastened together (via bands 22 and 32 fastened toopposing body portion 20 and spine portion 30). In this situation,fitting would be done by holding the free end of the body portion 20against the limb and wrapping the garment around the limb so that spineportion 30 encircles the limb and overlaps back onto the outside of thefree end of body portion 20. Spine portion 30 is then attached to bodyportion 20 so that the garment is as snug as possible. Further fittingis achieved by pulling on each individual hook tabs 34 in order to mimicthe limb contour and further shape the fit of the garment to match theshape of the limb.

Once the garment has been fitted and the body and spine portions arefully secured together, the garment is removed by disengaging thejuxtaposed bands 22 and 32. Once removed, the body-to-spine attachmentcan further be secured by smoothing out the material or making minoradjustments for clean transitions between the spine hook tabs 34. Theexcess material can be trimmed following the inside edge of the spinehook tabs 34.

FIGS. 6A and 6B illustrate a second embodiment of the invention in whichspine portion 30 has a straight edge opposite to the side from whichbands 32 extend. Specifically, FIG. 6A shows an interior (i.e.: surfaceto be put against the skin) of the garment. FIG. 6B shows acorresponding exterior view after bands 22 and 32 have been attachedonto the outside surface of the garment. In previous Figures, a curvededge on spine 30 increases the ability of the spine portion 30 tocontour to the limb. This is because the circumference at the ankle isgenerally smaller than the circumference at the calf, which creates acurved contour. Thus, the curved edge spines (seen in FIGS. 1A to 5B)best match the curves of the limb profile. In contrast, the use of astraight spine (FIGS. 6A and 6B) would force the material to stretch andadjust more than with a curved spine. Thus, in the embodiment of FIGS.6A and 6B, garment 10 is preferably made out of elastic or limitedstretch material. As also seen in FIGS. 6A and 6B, body portion 20 mayhave cut away tabs 23 permitting a user to cut away a top (or bottom)portion of the device, thereby shortening the length of the device onthe body limb. Specifically, the user could cut off a portion of theheight of the device by cutting horizontally across body portion 20along dotted line one of dotted lines 27. Similarly, cut away tabs maybe found on spine portion 30 to trim the height of spine portion 30.Alternatively, as illustrated, the Velcro® fasteners on the ends of band32 may have gaps 37 there between. Should the user wish to trip theheight of the garment (i.e.: it's length along the body limb), the usercould cut off a portion of the height of the device by cuttinghorizontally across spine portion 30 along one of the illustrated dottedlines.

Also in this embodiment, body portion 20 has measurement indicia thatdesignate more general sizes such as small, medium, large andextra-large (S, M, L, XL). Lines can be drawn from top to bottom on body20 such that a user with a “small” leg cuts along a line 24A whereas auser with a “medium” leg cuts along a line 24B to discard portion 20A.Such lines 24A, 24B, etc. provide a “rough guide” as to the size ofportion 20A to discard. Note: similar lines (which may either bemarkings or perforations) could be used with the garment of FIG. 1A as amethod of removing a significant portion of the unused body portion 20Aprior to performing a final adjustment to the spine location thusallowing the patient to easily test the spine placement before removingthe remaining portion of the body portion 20.

One advantage of the present system is that the need for time-consuminglength adjustments is eliminated. Instead, only two predetermined lengthmodels (i.e.: body portion 20 and spine portion 30) need to be stocked.This advantageously decreases needed inventory space.

Currently all adjustable designs in the market rely on trimming bandlength and/or adjusting its angle to fit the garment to the limb. Thecurrent invention adjusts the body of the garment to match the contourof the limb independently of any band adjustment. Current compressiongarments with spines or a second set of bands that are used foradjustment have overlapping adjustment points which make them difficultto use. In contrast, the present invention requires the securing of onlythree tabs 34 and the trimming of one piece 20, as compared to thetrimming and angling of several bands.

In existing compression devices, length adjustment is typically done bycutting off a complete set of bands. In contrast, the present inventiontrims the width of a band so as to keep gradient compression and not tocut through any assembled materials that could fail due to the cut. Inaddition, the present invention is a one-layer system, as compared tothe three or four layers typically used in bandaging approaches.

Regardless of compression band engagement design (overlap,juxtaposition, interlock, d-ring, etc.), the present design can beconverted to a one-size-fits-all garment. It will also match the legcontour regardless of where the fit is made circumferentially on thelimb. If the user applies the fitting spine to the shin area whilefitting, but then positions it to the back of the calf so thecompression bands are easily accessible in the shin area forapplication, the garment will still match the contour of the limb.

All previous compression garment models rely on a spine or curve pointthat is centrally/symmetrically located on the garment. For trim to fitversions, material is cut equally on each side of the garment or fromband ends. In contrast, the present invention is unique in that it canquickly and easily be adjusted to match the contour of the limb with orwithout falling on a central point in the garment.

Fitting and applying the garment to appropriate compression cantypically be done in less than five minutes. This is far superior to thetime involved with bandaging a limb, sizing and fitting a standard sizegarment, or measuring and producing a custom-made garment.

Optionally, the present invention also includes a “Built-In PressureSystem™” and guide card. The patient's ankle circumference measurementdetermines the appropriate range on the Built-In Pressure System cardfor the patient. This eliminates the need to translate the patient'sankle circumference into a nominal size, furthermore simplifying thefitting process. The Built-in Pressure System card allows the patient toadjust the garment to the prescribed amount of compression.

FIG. 7A is a third embodiment of the present invention in which garment10 has D-rings 35 attached to the ends of bands 32. In this embodiment,the ends of bands 22 are placed through D-rings 35 and then attachedback onto themselves. As can be seen in this embodiment, the bands 32can be quite short, and may simply be short projections on spine portion30 onto which the D-rings 35 are attached. As can also be seen, bands 22can be quite long in this embodiment as they are long loops of materialsthat weave through D-rings 35 and then attached back upon themselves.The advantage of such a D-ring system is that it allows the patient totighten the garment using only one hand. Note as well that themeasurement indicia are found on spine portion 30 in this embodiment ofthe invention. Only two spine tabs 34 are used.

FIG. 7B is quite similar to FIG. 7A, however, instead of D-rings on theends of bands, the spine portion 30 instead has holes 38 passingtherethrough. Bands 22 are passed through holes 38, and are then loopedback upon themselves. FIG. 7B illustrates the fact that the presentinvention is not limited to devices that have bands extending from bothof the body and spine portions. Instead, either of the body and spineportions need not have bands extending therefrom, all keeping within thescope of the present invention.

FIG. 8 is a fourth embodiment of the present invention in which garment10 has bands 22 and 32 which are not juxtaposed between one another.Instead, each band 22 is simply fastened onto a respective band 32(preferably by Velcro® hook and loop fasteners). Body portion 20 has aplurality of numbered perforations (lines 1,2,3,4,5,6) allowing unusedportion 20A to be removed more easily. This embodiment further includesan elastic wrap 50 for applying compression to an area of the limb thatwould be difficult to cover (such as the foot or hand), or whereflexibility is needed (such as the elbow or knee). Elastic wrap 50 couldalso be used to cover the junction between garments when using twogarments 10 to cover different segments of the limb. It could also bemade of a nonslip material to anchor the garment in place and extendfrom the top of the garment instead.

FIG. 9 is a fifth embodiment of the present invention in which garment10 has an intermediary portion 60 is positioned between body portion 20and spine portion 30. Preferably, intermediary portion 60 is attached tobody portion 20 by hook and loop fasteners, and spine portion 30 isattached to intermediary portion 60 by hook and loop fasteners. Thus,body and spine portions 20 and 30 are connected together by way ofintermediary portion 60. A number of intermediary portions 60 can bekept on hand to prevent the waste of cut away portions 20A as thepatient's limb changes in circumference over time. As can also be seen,bands 22 and 32 may be made of different widths along the length of thegarment (for example with narrower bands at the ankle/wrist and widerbands at the calf/elbow), as shown. Also in this embodiment, bands 32may have pockets 37 that can be used to hold one side of the garment inplace while the other side is wrapped over and attached.

FIG. 10 is a sixth embodiment of the present invention in which garment10 has bands 22 having ends that are received through holes 37 in bands32. Such interlocking bands provide conformity to the shape of the bodylimb. Also included is an ankle/foot wrap portion 70 for applyingcompression to the ankle-foot region. As can also be seen, there areindicia (S, M, L, XL) printed on body region 20 (for positioning spineportion 30). Tabs 34 can be attached to connect spine portion 30 ontobody portion 20 at the preferred (i.e.: S, M, L, XL) locationcorresponding to the size of the patient's limb. A tension measuringcard 80 may also be included in the device as sold. The tensionmeasuring card 80 has scales relating to the size of the patient's limb.Tension measuring card 80 relates the distance that the garment isstretched to the tension in the garment bands by measuring the spacingbetween lines printed on the garment as the garment is stretched.

FIG. 11A is a seventh embodiment of the present invention in whichgarment 10 (i.e.: both body portion 20 and spine portion 30) are made ofa thick material such as foam laminate with directional seams 29 and 39are sewn in to create alternating channels of high and low pressurerunning along the interior of the garment along the body limb. Suchalternating channels of high and low pressure may facilitate drainage oflymphatic fluids. Velcro® stays 40 may be used to further secure tabs 34to body portion 20. FIG. 11D shows a close-up profile view of thisattachment. FIG. 11B is a profile view of the attachment of band 22 backonto body portion 20 (after the end of band 22 has been juxtaposedbetween two bands 32). FIG. 11C is a profile view of a portion of thegarment of FIG. 11A showing directional seams 29 running along bodyportion 20. As can be seen, the vertical profile (i.e.: thickness) ofthe connection in FIG. 11B is higher than the vertical profile (i.e.:thickness) of the connection in FIG. 11D. This can be advantageous inthat it makes it easier to detach the bands 22 and 32 than to detach thebody and spine portions 20 and 30. In this embodiment, the bands 22 and32 extending across the front of the body limb adhere with a lesserstrength than the attachment of the spine and body portions 20 and 30across the back of the body limb.

FIG. 12A is a reverse side view of the garment shown in FIG. 11A. Thedotted area 90 is an area where an optional bladder or foam may be addedto distribute pressure. Similarly, area 92 represents a region where anulcer is often present (just above the ankle) and spot pressure isrequired. Foam or bladder piece 94 is positioned in dotted area 90 FIG.12B is a corresponding profile view.

FIG. 13A is simplified view of an eighth embodiment of the presentinvention in an open position. FIG. 13B is the garment of FIG. 13A in aclosed position. In this embodiment, garment 100 is a one-piececylindrical structure. (In FIGS. 13A and 13B, the exterior straps of thegarment have been removed for clarity of illustration. The exteriorstraps are shown in FIG. 13C). The device is first supplied as shown inits “open” position of FIGS. 13A and 13C. An adhesive tab 110 isprovided on the outside of the cylindrical device. Garment 100 is eitherplaced on the body limb, and then “closed” to the position shown in FIG.13B; or alternatively, garment 100 may be closed and then fitted overthe body limb. In operation, adhesive tab 110 (which may compriseVelcro®) is simply pulled forward and attached onto the body of thecylinder, as shown. This causes garment 100 to be folded over ontoitself (to the position of FIG. 13B), thereby narrowing thecircumference of the garment (such that it applies therapeutic pressureto the limb). Similar to the embodiments described above, thepositioning of adhesive tab 110 may be set such that it best conforms tothe shape of the particular patient's limb. Therefore, measurementindicia may be printed on the outside of garment 100 (either along thetop and bottom edges and/or along the mid section of garment 100). Theuser therefore simply moves adhesive tabs 110 to a preferred positioncorresponding to the measurement indicia. For some patients, the top tab110 may be moved farther forward before being attached to garment 100(e.g.: if the patient has a thinner calf). For some patients, the bottomtab 110 may be moved farther forward before being attached to garment100 (e.g.: if the patient has a thinner ankle region). FIG. 13C showsexterior bands or straps 22 and 32 (which are attached to the exteriorof the garment on the opposite side as shown in FIG. 13C). Bands 22 and32 are used to tighten the garment around the patient's limb, using thesame system as was described above. FIG. 13D corresponds to FIG. 13B andshows the folded over section 120 when garment 100 is moved to its“closed” position about the body limb. It is to be understood that invarious embodiments of the device, folded over section 120 may betrimmed off and removed for patient comfort. This would result in agarment operating essentially the same as a two-piece (spine and body)device as described above.

FIGS. 14A and 14B show an alternate embodiment of the present inventionwhich uses one or more guide bands 200. In FIG. 14A, a single guide band200 is used. In FIG. 14B, a pair of parallel guide bands 220A and 200Bare used.

Guide bands 200 operate to wrap together with body portion 20 around alimb prior to bands 22 and 32 wrapping body portion 20 and spine portion30 together around the limb.

Preferably, bands 200 have a fixed end 202 and a free end 204. Fixed end202 is attached (e.g.: sewn or glued) to body portion 20. Free end 204is preferable connected to body portion 20 by hook and loop fastenersand is thus positionable on body portion 20. As a result, guide band 200can be adjusted such that its circumference and positioning around thebody limb is optimal. In operation, the guide bands 200 can be used as aguide sleeve once the garment has been sized to the user. This allowsthe user to slide the garment on and place it in a desired position onthe limb before donning the compression bands (i.e.: tightening thegarment around the limb). As such, the user need not hold the device inplace by first securing the top two bands in position (and then startapplying the bottom bands with compression, working their way back up tothe top. FIG. 14C shows an alternate embodiment with guide band 200being attached at one end 204 to spine 30 and the other end 202 attachedto body portion 20. In this embodiment, the band 200 in FIG. 14C may bemade of two pieces that can be fastened together, as shown.

FIGS. 15A to 15D show an alternate embodiment of the invention in whichthe garment forms a non-planar shape when the body and spine portionsare secured together (prior to the garment being wrapped around the bodylimb). The advantage of this particular non-planar shape is that oncethe two portions are fastened together, the garment forms a contouredshape that matches the shape of the user's limb. In the case of a knee(or elbow), the contouring is especially helpful in that it reducesbunching that often occurs during flexion.

FIG. 15A shows the shapes of the body and spine portions prior to beingsecured together. Body portion 20 has a first side 25 (from which bands22 extend) and an opposite second side 27. Similarly, spine portion 30has a first side 35 (from which bands 32 extend) and an opposite secondside 37. The operation of the body and spine portions and theirassociated bands is similar to that described above. However, what isdifferent in the embodiment of FIGS. 15A to 15D is the novel geometry ofsides 27 and 37 which when attached together give the garment anon-planar shape prior to the garment being wrapped around the limb of apatient. By joining the second side 27 of the body portion 20 and thesecond side 37 of the spine portion 30, the garment is given its novelnon-planar shape.

In preferred aspects, at least one (or both) of the body and spineportions are dimensioned to be narrower across their mid-sections thanacross either or both of their top and bottom edges. Specifically, bodyportion 20 is narrower across its mid-section 29 than across either ofits top edge 21 or bottom edge 23. Similarly, spine portion 30 isnarrower across its mid-section 39 than across either its top edge 31 orits bottom edge 33. Stated another way, the second sides 27 and 37 arecurved inwardly at their mid-sections and outwardly at one or both oftheir top and bottom edges. It is also to be understood that one or bothof the body and spine portions may be curved inwardly at itsmid-section. For example, edge 27 may be curved while edge 37 isstraight, or vice versa; or both of edges 27 and 37 may be curved. Thisillustrated embodiment is particularly useful if the center of thegarment is applied around a knee or elbow. Conversely, however, if thecenter of the garment is instead applied around a calf, then themid-sections 29 and 39 may instead be wider than the top and bottomedges 21, 31 and 23, 33, respectively. It is to be therefore understoodthat the present invention encompasses embodiments with the mid-sectionof the garment being wider or narrower than the top and bottom edges.

In preferred embodiments, indicia will run along not only the top andbottom edges (21,31 and 23,33 respectively) of the garment. In addition,indicia will also preferably run along the mid-sections 29,39 of thegarment as well. As such, optimal sizing and placement of the body andspine portions can be achieved, and the garment will achieve its desiredcontoured shape.

FIGS. 15B to 15D illustrate the novel non-planar shape the garmentassumes when edges 27 and 37 are connected or held together. Edges 27and 37 may be sewn together at their edges, and/or they may be heldtogether by connector 300. Connector 300 preferably spans across edges27 and 37 as shown. Connector 300 may be sewn or glued directly ontobody portion 20 and spine portion 30. Alternatively, connector 300 maybe attached to body portion 20 and spine portion 30 by hook and loopfasteners.

As can be seen, connector 300 may be formed from a continuous body ofmaterial with a series of notches 302 extending along one or both sidesof the body, as shown. Notches 302 permit connector 300 to flex in alateral direction (perpendicular to the central axis of connector 300).In preferred aspects, notches 302 extend across more than half the widthof the connector.

What is claimed is:
 1. A therapeutic compression garment, comprising:(a) a body portion having a first side and a second side, with aplurality of bands extending from the first side; and (b) a spineportion having a first side and a second side, with a plurality of bandsextending from the first side, wherein the bands extending from thefirst side of the body portion and the bands extending from the firstside spine portion attach the body and spine portions together when thebody and spine portions are wrapped around a body limb, wherein thesecond sides of the body and spine portions are attached together, andwherein at least one of the body and spine portions is narrower or wideracross its mid-section than at either or both of its top and bottomedges such that the garment assumes a non-planar shape when the body andspine portions are attached together.
 2. The garment of claim 1, furthercomprising measurement indicia running along the top edges, mid-sectionsand bottom edges of the body and spine portions.
 3. The garment of claim1, wherein both of the body and spine portions are narrower or wideracross their mid-sections than at either or both of their top and bottomedges.
 4. The garment of claim 1, wherein the second sides of either ofthe body and spine portions are curved inwardly or outwardly at themid-section and outwardly or inwardly at the top and bottom edges. 5.The garment of claim 1, wherein the second sides of both of the body andspine portions are curved inwardly or outwardly at their mid-sectionsand outwardly or inwardly at their top and bottom edges.
 6. The garmentof claim 1, wherein the second sides of the body and spine portions areconnected together edge to edge along their second sides.
 7. The garmentof claim 6, wherein the second sides of the body and spine portions aresewn together.
 8. The garment of claim 1, wherein the second sides ofthe body and spine portions are secured together by a connector spanningthe edges of the body and spine.
 9. The garment of claim 8, wherein theconnector comprises a body having a series of spaced apart notchesrunning along at least one side of the body.
 10. The garment of claim 9,wherein the notches permit the connector to flex in a lateral direction.11. The garment of claim 9, wherein the notches extend across more thanhalf the width of the connector.
 12. The garment of claim 8, wherein theconnector is attached to each of the body and spine portions by hook andloop fasteners.
 13. The garment of claim 1, wherein the bands extendingfrom the body portion are juxtaposed between the bands extending fromthe spine portion when the body and spine portions are wrapped togetheraround a body limb.
 14. The garment of claim 1, wherein the bandsextending from the body portion are attached onto the spine portion andthe bands extending from the spine portion are attached onto the bodyportion when the body and spine portions are wrapped together around abody limb.
 15. A therapeutic compression garment, comprising: (a) a bodyportion having a plurality of bands extending from one side; and (b) aspine portion having a plurality of bands extending from one side,wherein the bands extending from the body portion and the bandsextending from the spine portion attach the body and spine portionstogether when the body and spine portions are wrapped around a bodylimb, and wherein the spine portion is releasable attached onto the bodyportion such that the spine portion is positionable at differentlocations on the body portion; and (c) at least one guide band connectedto the body portion, wherein the guide band is dimensioned to wraptogether with the body portion around the body limb.
 16. The garment ofclaim 15, wherein one end of the guide band is fixed to the body portionand the other end of the guide band is releasably attached to the bodyportion.
 17. The garment of claim 16, wherein the end of the guide bandthat is releasably attached to the body portion is attached by hook andloop fasteners.
 18. The garment of claim 15, wherein the at least oneguide band comprises a plurality of guide bands.
 19. The garment ofclaim 15, wherein one end of the guide band is attached to the bodyportion and the other end of the guide band is attached to the spineportion.